Associate Product Support Scientist

JOB DESCRIPTION:

The Associate Product Support Scientist role will support and assist in a variety of technical support activities within Operations. This position will investigate issues through root cause analysis and implement correction actions through use of the Quality Management System supporting Production and Quality Control groups through continuous improvement.

Location: Onsite - Position is based in Madison, WI

Hours: 1st shift, 8am-4:30pm

Essential Duties

Include, but are not limited to, the following:

• Provide technical and product support to Operations working cross-functionally with the Production, QC, Supply Chain, R&D, and Quality teams.
• Perform investigative testing for Out of Specification events (OOS), non-conformances (NCMRs), and corrective action preventive action (CAPA) plans through root cause investigation, experiment design, study execution, data analysis, and reporting.
• Provide support for PCR-based and/or NGS-based reagents and products.
• Provide support to Operations teams for qualifying new raw materials and alternative supply channels for products.

• Demonstrated proficiency in a variety of basic laboratory skills and techniques.
• Basic knowledge base in Molecular Biology, Biochemistry, Biotechnology, Chemistry, or a related field.
• Good understanding of in-vitro diagnostic product manufacturing processes and relevant assays (e.g. biochemical, RT-PCR, and NGS).
• Program, operate, and troubleshoot complex instrumentation such as microplate readers, real-time and digital polymerase chain reaction (PCR) instruments, next-generation sequencers, and liquid handling automation.
• Assist development and characterization of simple manufacturing processes incorporating industry standard techniques.
• Assist characterization of basic assay variability for simple measurement systems.
• Apply basic statistical techniques: assessing data normality, control charting and data trending, hypothesis testing, assessing variation, linear regression and model fitting.
• Analyze data to identify trends, assists troubleshooting and root cause investigation efforts with ability to utilize recognized root cause analysis tools.
• Assist investigations into analytical and functional assays, associated equipment, materials, and/or processes.

• Clearly and accurately generate experimental protocols, draft work instruction procedures, test methods, and summarize development activities through technical summary reports.
• Support Process and Test Method Validation readiness and execution.  Provide support and review in generating Validation documentation.
• Write new and edit existing Quality System documents (e.g. work instructions, standard operating procedures). Responsible for generating/driving corrective actions/action plans for changes.
• Collaborate with other departments (Quality Engineering, R&D, Regulatory Affairs, Supply Chain, Production, Validation, Quality Control) to achieve business results.  Able to meet objectives without negatively impacting other functions.
• Actively participates in project execution.
• Consistently hit deliverables as outlined by manager.
• Function independently with limited guidance from supervisor as well as part of a team. Adaptable to rapid changes in priorities, strong sense of urgency, and able to identify ways to work together to achieve results needed for all requests.
• Strong verbal and written communication skills.

• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work designated schedule.
• Ability to work nights and/or weekends, as needed.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% of a typical working day.
• Ability to work on a computer and phone simultaneously.
• Ability to use a telephone through a headset.
• Ability to work seated for approximately 80% of a typical working day. Ability to work standing for approximately 20% of a typical working day.
• Ability to lift up to 40 pounds on an occasional basis.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to use various types of laboratory equipment; including microscopes, microtomes, blades, strainers, and pipettes for extended periods of time.
• May perform repetitious actions using lab tools.
• Ability to use near vision to view samples at close range.
• May be exposed to hazardous materials, tissue specimens, and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
• Ability to work with blood, tissue, stool, or other human specimen samples.
• Ability and means to frequently travel between local Exact Sciences locations.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Bachelor’s degree in life sciences or field related to the essential duties of the job.
• 2+ years of experience in the life sciences industry. Master’s or Doctoral degrees may be considered in lieu of 2 years of experience.
• Proficient in MS Office Suite (Word, Excel, Outlook, PowerPoint).
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Proficiency with statistical analysis software and/or programming (e.g. JMP, R).
• Experience working within an FDA 21 CFR 820, ISO 13485, and/or cGMP structured environment.
• Experience with in-vitro diagnostic product development, design transfer, manufacturing, or product support.

• Experience in a biotech or molecular diagnostics laboratory with nucleic-acid–based workflows (e.g. PCR/qPCR). Familiarity with CAP/CLIA regulatory requirements as they pertain to in vitro diagnostics.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

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